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S. 1209

REMEDY Act

Reforming Evergreening and Manipulation that Extends Drug Years Act or the REMEDY Act

This bill addresses drug patents with respect to Food and Drug Administration (FDA) approval of a drug application.

Currently, when the owner of a brand-name drug approval sues a generic drug company for patent infringement based on the generic company's application for FDA approval of a generic version of the brand-name drug, there is generally a 30-month stay on the approval of the generic version. Under this bill, the stay goes into effect only if the lawsuit alleges infringement of a patent that claims the drug compound.

When the U.S. Patent and Trademark Office invalidates a patent for a drug, the FDA must update its list of relevant patents for the drug.

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Sen. Cassidy, Bill [R-LA](R-LA)Sponsor
7 cosponsors5 D2 R
7cosponsors1committees2actions1related bills3subjects
  1. IntroReferral

    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

    Health, Education, Labor, and Pensions Committee
  2. IntroReferral10000

    Introduced in Senate

REMEDY Act — Informed